Intravitreal Ranibizumab and TA Combination Therapy vs. Ranibizumab Monotherapy in Polypoidal Choroidal Vasculopathy

Aier School of Ophthalmology, Central South University120 enrolled

Overview

The purpose of this study is to evaluate the effects and safety of ranibizumab therapy combined with TA versus ranibizumab monotherapy in patients with polypoidal choroidal vasculopathy (PCV). Furthermore, the pharmacogenetics effect of inflammatory related genes polymorphism in response to the treatments. To further confirm the role of inflammatory factors in the pathogenesis and advance of PCV.

Polypoidal choroidal vasculopathy (PCV), a vascular disease of the choroid, appears to be the predominant subtype of exudative or "wet" AMD in Asian populations, in contrast to choroidal neovascularization secondary to AMD (CNV-AMD) in Western populations. There are distinct differences in pathophysiological, clinical and epidemiological factors between the two subtypes, although they also share some common risk factors. In contrast to CNV-AMD, PCV does not seem to respond as well to anti-VEGF treatment. The optimal treatment option for PCV remains elusive, with most studies showing good short-term visual outcome but poorer longer-term outcome with current treatment strategies. Therefore, understanding the pathogenesis of PCV, while developing novel and effective treatments strategies to prevent PCV-related vision loss is significant unmet needs. The purpose of this study is to assess the effects and safety of ranibizumab therapy combined with TA versus ranibizumab monotherapy in patients with PCV. Second, the pharmacogenetics effect of inflammatory related genes and polymorphism in response to the treatments of PCV will be explored. To further confirm the role of inflammatory factors in the pathogenesis and advance of PCV, it is important to determine the levels of inflammatory factors in the anterior chamber aqueous humor from PCV patients, comparing with the aqueous humor acquired from the age-matched age-related cataract patients undergoing phacoemulsification.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Wet Macular Degeneration

Interventions

Triamcinolone AcetonideDRUG

Intravitreal inject 0.5mg of Ranibizumab and 2mg of Triamcinolone Acetonide.

RanibizumabDRUG

Intravitreal inject 0.5mg of Ranibizumab.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * bestcorrected visual acuity (BCVA) letter score of 73 to 24 using Early Treatment of Diabetic Retinopathy Study charts at a starting distance of 4 m (20/40 to 20/320 Snellen equivalent); * a greatest lineardimensionof the lesion of \<5400 um( 9 Macular Photocoagulation Study disk areas), assessed by ICGA; * Cross-reading by different center to conﬁrmed diagnosis of PCV, that is, presence of early subretinal focal ICGA hyperﬂuorescence (appearing within the ﬁrst 6 minutes after injection of indocyanine green) and in addition, at least one of the following angiographic or clinical criteria: (i) association with a BVN, (ii) presence of pulsatile polyp, (iii) nodular appearance when viewed stereoscopically, (iv) presence of hypoﬂuorescent halo (in ﬁrst 6 minutes),7 (v) orange subretinal nodules in stereoscopic color fundus photograph (polyp corresponding to ICGA lesions), or (vi) association with massive submacular hemorrhage (deﬁned as size of hemorrhage of at least 4 disk areas). Exclusion Criteria: * received treatment previously with verteporﬁn PDT, focal laser photocoagulation, transpupillary thermotherapy, pneumatic displacement of subretinal blood, or any investigational treatment; * a history of angioid streaks, presumed ocular histoplasmosis syndrome, or pathologic myopia; * experienced RPE tear, retinal detachment, macular hole, or uncontrolled glaucoma; * undergone intraocular surgery (except uncomplicated cataract extraction with intraocular lens implantation within 60 days before the screening visit)

Locations (7)

Beijing Aier Intech Eye Hospital

Beijing, Beijing Municipality, China

Guangzhou Aier Eye Hospital

Guanzhou, Guangdong, China

Shenzhen Aier Eye Hospital

Shenzhen, Guangdong, China

Shenzhen Eye Hospital

Shenzhen, Guangdong, China

Outcomes

Primary Outcomes

Change of mean BCVA

Change of Central BCVA (Measured with EDTRS Chart,numbers of letters) (primary: baseline and 6 months, secondary: baseline to 12 months)

Time frame: 12 months

Secondary Outcomes

Change of Central Rerina Thickness

Change of Central Rerina Thickness (um) (primary: between baseline and 6 months, secondary: between baseline to 12 months)

Time frame: 12 months

regression of Branch vacular network(BVN)

Size of Branch vascular network (um)

Time frame: 12 months

Polyps regression

Size of polyps (um)(primary: between baseline and 6 months, secondary: between baseline to 12 months)

Time frame: 12 months

Number of re-treatments

re-treatments numbers

Time frame: 12 month

Data from ClinicalTrials.gov

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